Job Title: Document Specialist - Regulatory Compliance
About the Role
The Document Specialist - Regulatory Compliance will play a crucial role in ensuring the accuracy and integrity of essential documents in compliance with regulatory requirements, industry standards, and company policies.
Key Responsibilities
* Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolio of studies in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Escalate any TMF Quality issues in a timely manner to RMC Lead.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
Requirements
* Proficiency in using an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in a fast-paced, deadline-oriented environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Preferred Qualifications
* University Degree preferred (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry (desirable).